FDA panel votes against Mevacor Daily OTC switch

SILVER SPRING, Md. —It’s safe. It’s effective. But again it was the lack of appropriate self-selection that scuttled Merck’s third attempt at switching its Mevacor statin from prescription to over-the-counter status.

A pair of Food and Drug Administration advisory panels last month voted 10-2 (with one abstention) against the switch of Merck’s Mevacor 20 mg, suggesting that a statin will not be switched to OTC in this country. While the FDA may yet approve Mevacor Daily—the chosen trade name for the OTC lovastatin—the agency only acts against the advice of its advisory panels on rare occasions.

The anticipated action date on whether to approve an OTC Mevacor Daily is slated for Jan. 26, Merck has reported.

While Merck improved self-selection scores in a consumer label-comprehension study from two years ago, FDA advisers raised concerns that a few patients reported they would substitute an OTC statin in place of their prescribed statin, suggesting that they may move from being adequately protected against potential heart disease to underprotected.

“The switching issue is the one that’s troubling,” said one member of the panel. “If you switch from a stronger prescription medicine, if you use [Mevacor Daily] instead, to me that would be much more likely to happen if this over-the-counter drug was very cheap,” he said.

Even new partner GlaxoSmithKline, which signed on to the Mevacor switch team as the consumer healthcare distributor a month before the FDA meeting, could not sway the majority of advisory panelists from nay to yea.

“GlaxoSmithKline has a [proven] track record…for first-in-class switches,” noted George Quesnelle, president of consumer healthcare for North America for GlaxoSmithKline, during his presentation in support of the switch. As examples, Quesnelle pointed to the company’s successful switch of such complicated regimens as smoking cessation products and the diet aid Alli. If switched, non-branded education to help raise awareness around statins will be launched into the marketplace, Quesnelle said, long before Mevacor Daily actually hits shelves.

Merck’s new studies found that more consumers correctly self-selected as compared with 2005. “For the small fraction that made a mistake” the chance of a serious adverse event is extremely low, noted Edwin Hemwall, Merck’s executive director of worldwide OTC regulatory and scientific affairs. Indeed, consumers approached a 90-percent level in making appropriate decisions regarding the use of Mevacor Daily, Hemwall said.

“We know that Mevacor Daily is indicated for a motivated, [health-conscious] consumer,” Quesnelle said. GlaxoSmithKline’s marketing initiatives were submitted along with the application, he added.

To help consumers with self-selection, Merck made label revisions, including a highlighted age-exclusion graphic on the front of the package and a stronger warning against the use of Mevacor Daily in women who are pregnant or could become pregnant.

Merck presented usage studies of two labels—one that asked consumers to evaluate whether they should take Mevacor Daily based in part on their knowledge of their total cholesterol scores and one that based that evaluation on a consumer’s low-density lipid levels. Merck concluded that consumers were more familiar with their total cholesterol levels.

Merck also proposed selling Mevacor Daily “on the open shelf but only in those stores with pharmacies.” Limiting distribution to stores with pharmacies affords the consumer convenient access to a healthcare professional should they have questions.

However, the new studies did not alleviate all of the FDA’s concerns over appropriate self-selection. In the usage study based on a consumer’s knowledge of their LDL levels, for example, 98 percent of consumers appropriately chose not to take the medicine, but only 16 percent of those who chose to take the medicine did so appropriately.

In addition, more than 30 percent of participants who already were taking a lipid-lowering drug stated that it would be appropriate for them to use an OTC statin. Of those, 55 percent would replace their current lipid therapy with the Mevacor Daily, and 28 percent would take Mevacor Daily in conjunction with their current statin therapy. Half of those already on a statin regimen would make the switch to Mevacor Daily based on cost concerns, with the assumption that an OTC medicine would be cheaper than their prescription-drug co-pays; 29 percent cited improved convenience in buying Mevacor over-the-counter; 15 percent said an OTC statin would mean they wouldn’t have to see their doctor as often; and 11.3 percent opined that OTC medicines present fewer side effects than their prescription-only drugs.

“I was…concerned about the reasons why people decided they would rather have an OTC [statin],” commented Mary Tinetti, chairman of both the meeting and the nonprescription drugs advisory committee. “Things like…it was ‘safer and more natural [because it was OTC].’ Obviously, that’s not the case. It just tells us that at this point we’re not in a situation where people can make that [qualitative] decision.”

“We felt we presented a compelling case to the committee that nonprescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors and are already talking with their healthcare provider,” stated Edwin Hemwall, Merck’s vice president of global OTC regulatory and scientific affairs.

The next question is whether Merck will make a fourth switch pitch for its Mevacor statin. A GlaxoSmithKline spokesman declined to speculate on that possibility following the vote, though with the last-minute addition of GSK to the switch process, a fourth attempt benefiting from GSK’s switch expertise may be in the realm of possibility.

The FDA certainly wouldn’t object. When asked during a press conference if the latest vote against an OTC Mevacor amounted to “three strikes and you’re out,” Andrea Leonard-Segal, FDA director of the nonprescription clinical evaluation division of the office of nonprescription products, said no. “We are open-minded [at the FDA],” she said.

S&P revises outlook on Rite Aid

NEW YORK Standard & Poor’s Ratings Services revised its outlook on chain drug retailer Rite Aid to negative from stable, the firm reported Friday. At the same time, S&P affirmed the ‘B’ corporate credit rating on Rite Aid.

“The outlook change reflects the company’s weak same-store sales and our expectation that this trend will continue over the next few quarters,” stated Standard & Poor’s credit analyst Diane Shand. Rite Aid faces a more cautious consumer, strong growth of lower-priced generics and intense competition, she said. In addition, the current environment could make it more challenging for the company to integrate its recently-acquired Brooks/Eckerd stores.

Boston Mayor decries in-store health clinics

BOSTON On the heels of the Massachusetts Public Health Council approving regulations allowing for in-store health clinics in the state, Boston Mayor Thomas Menino is reportedly looking to ban the clinics from opening in the city.

The decision by the health council “jeopardizes patient safety,” Menino said in a written statement, according to a Boston Globe report. “Limited service medical clinics run by merchants in for-profit corporations will seriously compromise quality of care and hygiene. Allowing retailers to make money off of sick people is wrong.”

The newspaper also reported that, in a separate letter, the mayor urged members of the city’s Public Health Commission to consider banning the clinics from opening within Boston. CVS has plans to open 20 to 30 MinuteClinics in the Greater Boston area but it is unclear how many of those would be within the city’s limits.

Defending its decision to allow clinics to operate, the state Public Health Council issued a statement that read: “The members of the Public Health Council were deliberative and thoughtful in their review of the limited service clinic regulation. We believe these types of clinics, operated either as part of a retail operation or in a nonprofit setting, can provide the public access to safe, convenient, and quality care for minor health issues.”

Officials at MinuteClinic were not immediately available for comment.

On Jan. 9, the state Public Health Council approved rules for limited service medical clinics. The new regulations took effect immediately.

“This is a new model for health care delivery that can benefit many people in the Commonwealth. These regulations will improve consumer convenience and make it easier for non-profit organizations to establish satellite clinics in a variety of settings to serve vulnerable populations,” stated secretary of Health and Human Services JudyAnn Bigby in a statement issued after the approval.

Added John Auerbach, commissioner of the Department of Public Health and chair of the PHC, “Properly regulated, these types of clinics will serve an important function, making care for minor medical care more convenient. The council was mindful of not wanting to create a stand-alone system of health care, so these regulations require coordination and linkages to primary care providers.”

The approval came at the end of a long review process that included two public hearings and the submission of hundreds of pages of testimony regarding the regulations, including testimony in favor of the clinics from the Convenient Care Association.

“We appreciate the Public Health Council’s careful deliberation regarding the adopted regulations that will now guide the operation of limited services clinics in Massachusetts. These retail-based clinics are providing consumers in 35 other states with easy access to high-quality, affordable health care in the face of a nationwide primary care physician shortage. Since this growing shortage is well documented in Massachusetts, and its related health care access issues have been exacerbated by the state’s near-universal healthcare coverage, we appreciate the Council embracing limited services clinics as a partial solution to these serious problems,” said Web Golinkin, president of the CCA and chief executive officer of in-store clinic operator RediClinic, in a statement issued after the council’s decision.

Sparking the move to create specialized regulations for these clinics was CVS’ application to open a MinuteClinic in one of its stores in Weymouth. According to the council, early in the application review process it became clear that DPH regulations governing medical clinics did not address the operation of medical clinics with limited scope of services. Rather than consider applications requiring numerous waivers from full-service clinic regulations, the department decided to create a specialized set of rules.

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